Alpine, Evotec Expanding Production of ALPN-303, Potential Therapy

Experimental lupus treatment aims to prevent inflammatory attacks

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Alpine Immune Sciences and Evotec announced the expansion of an agreement to manufacture ALPN-303, an experimental anti-inflammatory therapy that Alpine is developing for systemic lupus erythematosus (SLE) and other diseases driven by immune B-cells.

Under the initial 2020 agreement, Evotec’s subsidiary Just-Evotec Biologics used its continuous manufacturing platform, called J.DESIGN, to produce ALPN-303 for use in ongoing Phase 1 and anticipated Phase 2 clinical testing. With the expansion, Just-Evotec will utilize its platform to develop a process allowing ALPN-303 to be made at a scale suitable for commercialization.

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“We are excited to continue our highly collaborative partnership with the innovative team at Alpine to support the development of a commercial process for ALPN-303,” Linda Zuckerman, PhD, executive vice president and global head of biotherapeutics at Just-Evotec, said in a company press release.

ALPN-303 targets B-cell growth and activation

ALPN-303 is designed to inhibit the activity of B-cells, a type of immune cell that plays a key role in the autoimmune inflammatory attack that drives lupus.

It works by blocking the activity of two signaling molecules that promote B-cell growth and activation, called B-cell activating factor (BAFF or BLyS) and a proliferation inducing ligand (APRIL). The experimental therapy was created by modifying part of a protein receptor called TACI, which normally binds to these signaling molecules.

Alpine is sponsoring a Phase 1 trial (NCT05034484) evaluating the safety and pharmacological profile of ALPN-303 in healthy volunteers. The study is recruiting participants at locations in Brisbane and Melbourne, Australia. It is open to adults, ages 18–65, who are fully vaccinated against COVID-19, among other criteria.

“ALPN-303 is a highly differentiated and promising therapeutic candidate with the potential to treat challenging target diseases such as lupus and other B-cell related inflammatory diseases,” said Wayne Gombotz, PhD, chief technology officer at Alpine.

Just-Evotec’s J.DESIGN platform uses artificial intelligence and machine learning, alongside other processes, to facilitate the development of biologics — medicines that require the use of living cells in the manufacturing process.

“We are excited to be leveraging Just – Evotec Biologics’ J.DESIGN platform to bring this important therapeutic to late-stage clinical development,” Gombotz said.

The company’s biomanufacturing facility is located in Redmond, Washington state.

“We are proud to support Alpine in its endeavour to further develop ALPN-303,” added Craig Johnstone, PhD, Evotec’s chief operating officer.